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Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

Primary Purpose

Cardiac Arrest, Comatose

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

ThermoSuit(R) System

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring resuscitation, hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
Initial (pre-resuscitation) cardiac rhythm of ventricular fibrillation, non-perfusing ventricular tachycardia, pulseless electrical activity, or asystole.
Estimated or known age > 18 years.
Intubation, ventilation and placement of esophageal probe.
Persistent neurologic dysfunction i.e. comatose upon enrollment [GCS ≤ 8].

Exclusion Criteria:

Height greater than 188 cm.
Elbow-to-elbow width greater than 60 cm (as measured above the supine patient).
Core temperature less than 35°C after ROSC (as measured at the tympanic membrane, esophagus, sub-lingual space,nasopharynx, or central blood vessel).
Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system.
Known pregnancy.
Response to verbal commands after ROSC (but before enrollment).
Known terminal illness that preceded the arrest.
Known enrollment in another study of a device, drug, or biologic.
Major trauma or other co-morbidity requiring urgent surgery.
Improving neurologic status.
> 4 hours since return of spontaneous circulation.
Unknown time of arrest.
Severe or known coagulopathy (with active bleeding).
Hemodynamic instability despite vasopressors (SBP < 90 mmHg or MAP < 60 mmHg for > 30 minutes after ROSC and before enrollment).

Sites / Locations

General Hospital, University of Vienna

Outcomes

Primary Outcome Measures

Primary: Time from collapse to achieving desired range of cooling (32.0 to 34.0°C);

Time from deployment of the ThermoSuit™ (start of cooled water flow to patient) to core temperature < 34.0°C;

Total time during the first 24 hours after cooling is initiated that the core temperature is between 32.0 and 34.0°C.;

Protocol compliance: This is defined as the proportion of patients in whom compliance (i.e. target temperature range) is achieved 85% of the time.;

Ease of use of the TSS (evaluated by clinical staff using the Product Performance Assessment questionnaire, Appendix 7);

Duration of maintenance of hypothermia without supplemental cooling;

Ease of maintenance of hypothermia for 12 hours (whether or not supplemental cooling is needed)

Secondary Outcome Measures

Secondary: Total number of days in ICU;

Barriers to compliance;

Neurologic and physical status during in-hospital recovery;

Neurologic and physical status at discharge;

Neurologic and physical status at 30 ± 7 days follow-up for surviving patients;

Neurologic and physical status at 6 month ± 15 days follow-up.

Full Information

NCT ID

NCT00384319

First Posted

October 4, 2006

Last Updated

January 3, 2008

Sponsor

Life Recovery Systems

Collaborators

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00384319

Brief Title

Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

Official Title

Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Life Recovery Systems

Collaborators

Medical University of Vienna

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.

Detailed Description

The primary purpose of this study is to clinically evaluate the use of a new cooling device (the LRS ThermoSuit(R) System) to cool patients who are comatose following resuscitation from cardiac arrest. This device cools by circulating cold water directly against the skin of the patient. Cooling to a state of mild hypothermia (32 to 34 degrees C, maintained for 12 to 24 hours) is recognized by the American Heart Association, European Resuscitation Council, and the Canadian Association of Emergency Care Physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. It is hypothesized that this new device will cool patients much more quickly than by historical means. Patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest, Comatose

Keywords

resuscitation, hypothermia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

ThermoSuit(R) System

Intervention Description

The ThermoSuit device is used to cool patients using direct contact of the skin with cold water.

Primary Outcome Measure Information:

Title

Primary: Time from collapse to achieving desired range of cooling (32.0 to 34.0°C);

Time Frame

Day of treatment

Title

Time from deployment of the ThermoSuit™ (start of cooled water flow to patient) to core temperature < 34.0°C;

Time Frame

Day of treatment

Title

Total time during the first 24 hours after cooling is initiated that the core temperature is between 32.0 and 34.0°C.;

Time Frame

First day after treatment

Title

Protocol compliance: This is defined as the proportion of patients in whom compliance (i.e. target temperature range) is achieved 85% of the time.;

Time Frame

First day after treatment

Title

Ease of use of the TSS (evaluated by clinical staff using the Product Performance Assessment questionnaire, Appendix 7);

Time Frame

Day of treatment

Title

Duration of maintenance of hypothermia without supplemental cooling;

Time Frame

First day after treatment

Title

Ease of maintenance of hypothermia for 12 hours (whether or not supplemental cooling is needed)

Time Frame

First 12 hours after treatment

Secondary Outcome Measure Information:

Title

Secondary: Total number of days in ICU;

Time Frame

Time while patient is in ICU

Title

Barriers to compliance;

Time Frame

First day after treatment

Title

Neurologic and physical status during in-hospital recovery;

Time Frame

Time while patient is hospitalized

Title

Neurologic and physical status at discharge;

Time Frame

Time at which patient is discharged for hospital

Title

Neurologic and physical status at 30 ± 7 days follow-up for surviving patients;

Time Frame

30 ± 7 days after hospital discharge

Title

Neurologic and physical status at 6 month ± 15 days follow-up.

Time Frame

6 months ± 15 days after hospital discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC). Initial (pre-resuscitation) cardiac rhythm of ventricular fibrillation, non-perfusing ventricular tachycardia, pulseless electrical activity, or asystole. Estimated or known age > 18 years. Intubation, ventilation and placement of esophageal probe. Persistent neurologic dysfunction i.e. comatose upon enrollment [GCS ≤ 8]. Exclusion Criteria: Height greater than 188 cm. Elbow-to-elbow width greater than 60 cm (as measured above the supine patient). Core temperature less than 35°C after ROSC (as measured at the tympanic membrane, esophagus, sub-lingual space,nasopharynx, or central blood vessel). Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system. Known pregnancy. Response to verbal commands after ROSC (but before enrollment). Known terminal illness that preceded the arrest. Known enrollment in another study of a device, drug, or biologic. Major trauma or other co-morbidity requiring urgent surgery. Improving neurologic status. > 4 hours since return of spontaneous circulation. Unknown time of arrest. Severe or known coagulopathy (with active bleeding). Hemodynamic instability despite vasopressors (SBP < 90 mmHg or MAP < 60 mmHg for > 30 minutes after ROSC and before enrollment).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Holzer, MD

Organizational Affiliation

General Hospital, University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Hospital, University of Vienna

City

Vienna

ZIP/Postal Code

A-1090

Country

Austria

12. IPD Sharing Statement

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Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

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